US4770853A - Device for self contained solid phase immunodiffusion assay - Google Patents

Device for self contained solid phase immunodiffusion assay Download PDF

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Publication number
US4770853A
US4770853A US06/938,003 US93800386A US4770853A US 4770853 A US4770853 A US 4770853A US 93800386 A US93800386 A US 93800386A US 4770853 A US4770853 A US 4770853A
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labelled
chamber
ligand
receptor
reagent
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US06/938,003
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David Bernstein
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Aberlyn Capital Management LP
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New Horizons Diagnostics Corp
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Assigned to NEW HORIZONS DIAGNOSTICS CORPORATION, 9110 RED BRANCH ROAD, COLUMBIA MARYLAND 21045, A CORP. OF MD reassignment NEW HORIZONS DIAGNOSTICS CORPORATION, 9110 RED BRANCH ROAD, COLUMBIA MARYLAND 21045, A CORP. OF MD ASSIGNMENT OF ASSIGNORS INTEREST. Assignors: BERNSTEIN, DAVID
Priority to DE3750473T priority patent/DE3750473T2/en
Priority to AT88900311T priority patent/ATE110852T1/en
Priority to AU10518/88A priority patent/AU1051888A/en
Priority to PCT/US1987/003169 priority patent/WO1988004431A1/en
Priority to JP63500684A priority patent/JPH01502054A/en
Priority to EP88900311A priority patent/EP0293447B1/en
Publication of US4770853A publication Critical patent/US4770853A/en
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Priority to US07/818,439 priority patent/US5169789A/en
Assigned to ABERLYN CAPITAL MANAGEMENT LIMITED PARTNERSHIP reassignment ABERLYN CAPITAL MANAGEMENT LIMITED PARTNERSHIP ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: NEW HORIZONS DIAGNOSTICS CORPORATION
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/5302Apparatus specially adapted for immunological test procedures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0096Casings for storing test samples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B2010/0003Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements including means for analysis by an unskilled person
    • A61B2010/0006Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements including means for analysis by an unskilled person involving a colour change
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/15Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/38Swabs having a stick-type handle, e.g. cotton tips
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/04Closures and closing means
    • B01L2300/041Connecting closures to device or container
    • B01L2300/044Connecting closures to device or container pierceable, e.g. films, membranes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/06Auxiliary integrated devices, integrated components
    • B01L2300/0672Integrated piercing tool
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/06Auxiliary integrated devices, integrated components
    • B01L2300/0681Filter
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00Moving or stopping fluids
    • B01L2400/04Moving fluids with specific forces or mechanical means
    • B01L2400/0475Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
    • B01L2400/0478Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure pistons
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5029Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures using swabs
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5082Test tubes per se
    • B01L3/50825Closing or opening means, corks, bungs
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/52Containers specially adapted for storing or dispensing a reagent
    • B01L3/527Containers specially adapted for storing or dispensing a reagent for a plurality of reagents

Definitions

  • ligand receptor assays Many types have been developed and commercialized. These assays are less expensive if capital equipment can be eliminated, such as scintillation counters, fluorometers, and colorimeters in the case of radioimmunoassay, fluorescent immunoassay, and enzyme immunoassay respectively.
  • Non instrumental assays such as latex agglutination, enzyme immunoassays on strips, tubes, membranes or filters have increased the usefulness and ease of performance of immunodiagnostic testing, but are still cumbersome requiring washing steps, multiple reagent additions and usually refrigerated storage conditions.
  • amplification or growth of viruses and bacteria are desirable before testing to increase the sensitivity of detection.
  • adsorption steps to remove interferring substances or inhibitors of the ligand receptor assay, or long incubation of reagents are necessary to perform an assay. Each step for an assay increases the difficulty of testing for the minimally trained individual and any device that would reduce user error would improve diagnostic testing.
  • a number of antigens of interest in the diagnosis of infectious disease are collected with a sterile swab on a shaft to remove the organisms from the suspected infected area or test site (wounds, lesions, blood, tissues, pus, fluids, etc.).
  • the swab is generally used to transfer organisms to a suitable media for culturing which may take as long as 48 hours for growth of bacteria, and 2 weeks for viruses. If the organisms are viable and do grow, then their identification could be made by biochemical, morphological or immunological methods. This time consuming method is slowly becoming replaced by more rapid immunological testing methods or DNA probe methodologies.
  • the swab In many immunoassays that utilize a swab for collection of antigens or cells, the swab is placed in a solution to release the antigenic materials or cells after collection. It may be necessary to use enzymes, acids, detergents, etc. to solubilize or breakdown the antigens to expose antigenic determinants.
  • the extracted material can then be used in an immunoassay by removing the fluid from the swab and mixing it with other reagents or adding the other reagents directly to the swab extract.
  • membranes or filters are used to capture the immunoreactants, it is necessary to bring the fluid containing the immunoreactants in contact with the filter or membrane.
  • prefilter large pore size filter or membrane
  • amplification can be achieved if the organisms are first cultured and then tested. If the culturing and the testing could be performed in a single device, then testing would be simplified. In some assays where there are inhibitors, cross reactive products, or clotting factors, red blood cells, etc., it may be necessary to add adsorbant materials (i.e. beads, kaolin, antibody coated particles, antigen coated particles, or lectin coated particles), anticoagulants, or buffers etc. before the ligand receptor assay can be performed.
  • adsorbant materials i.e. beads, kaolin, antibody coated particles, antigen coated particles, or lectin coated particles
  • a swab or swab-like material a shaft with a porous or fibrous absorbant material at one end
  • test device that can be stored at nonrefrigerated temperatures, and can be utilized to perform an assay on a biological specimen or fluid without any additional reagents having to be provided to the test device.
  • test device which can utilize lyophilized reagents that can be reconstituted in situ within the device.
  • the present invention maximizes the safety and ease of performance of ligand receptor assays through the use of an apparatus designed to enable a biological specimen to be obtained by a collection device comprising a shaft and an attached adsorbant or absorbant porous or fibrous material (i.e. rayon, dacron, cotton swab) which is inserted into a cylindrical tube.
  • a collection device comprising a shaft and an attached adsorbant or absorbant porous or fibrous material (i.e. rayon, dacron, cotton swab) which is inserted into a cylindrical tube.
  • the cylindrical tube contains a sealed vessel or plurality of sealed vessels in sequential order and which the seal will break away or collapse when pressure of the collection device (swab) is exerted on the seal by physically pushing the collection device into and through each vessel.
  • These sealed vessels may contain media, extraction reagents, diluents, labelled antibodies, labelled antigens, labelled lectins,anticoagulants, adsorbants, inactivators, etc. which mix with the biological specimen collected on the collection device.
  • the reagents in these vessels may be lyophilized, enabling long term storage at non refrigerated temperature.
  • the vessels are fixed in position in the cylindrical tube to enable the seals to be broken when physical pressure is exerted on the shaft of the collection device.
  • the collection device holder has appropriate stop points to allow for the collection device tip to enter the appropriate vessel and mix with its contents.
  • a key feature of the vessels are that the tip and shaft of the collecting device can pass through each of the vessels into a lower portion of the cylindrical tube and an attached lower portion comprising a ligand receptor reaction area.
  • the ligand receptor area is comprised of a capture membrane or a filter that will allow unbound reactants to pass through by diffusion and retain the appropriate labelled members of the binding pair.
  • the capturing membrane or filter may be coated with a member of the binding pair to capture the reactants. If capture particles are used, then the capture filter is utilized to retain the particles and allow unbound free labelled antigen or antibody to diffuse through.
  • a prefilter may be used between the collector tip and the capture or filter to remove any nonspecific binding due to debris.
  • An additional absorbant material can be placed behind the capture membrane to increase the uptake of fluid. In either case a specific volume of reactant can be absorbed by controlling the size of the filters and absorbant materials.
  • the configuration of the lower portion allows the collection device to come into physical contact with the prefilter, capture membrane or capture filter.
  • FIG. 1 is a cross sectional view of the invention showing the collection device holder, the collection device, the tube, the sealed reagent compartments and the lower ligand receptor transfer area.
  • FIG. 2 is a perspective view of the basic structure of the collection device holder and collection device including the grooves for guiding the movement of the collection device through the apparatus.
  • FIG. 3 is a perspective view of the basic structure of the tube, its compartmentalized reagents, and the nodule which fits into the groove of the collection device holder.
  • FIG. 4 is a perspective view of the sealed compartments (i.e. vessels) of the apparatus.
  • FIG. 5 is a cross sectional side view of the lower portion of the apparatus showing the final position of the collection device tip at the window of the ligand receptor area.
  • FIG. 6 is an exploded perspective view of the ligand receptor test area.
  • the inventive apparatus comprises a collection device holder 14 which is comprised of a restrictive portion 1 that hold the shaft of the collection device 2 in place, a cylindrical tube 13 which is comprised of one or more sealed reagent compartments 15 and 20, and a lower ligand receptor reaction area 10.
  • the collection device holder 14 has a nodule 16 which positions onto the cylindrical tube and prevents the apparatus from being accidentally opened.
  • the collection device holder is removed and separated from the cylindrical tube by twisting and pulling up on the collection device holder. This frees up the collection device holder which is then used to collect the test sample (i.e. throat swab, pus, blood, urethral swab, etc.) by allowing the collection device tip 5 to come in contact with the suspect tissue, fluid, wound, etc.
  • the test sample i.e. throat swab, pus, blood, urethral swab, etc.
  • the collection device holder is replaced onto the cylindrical tube 13 and turned until the nodule 4 (FIG. 3) on the cylindrical tube is in alignment with the groove 18.
  • the collection device holder is then manually forced downward until the nodule 4 stops at the horizontal groove 19.
  • the tip 5 will have broken through the first seal (FIG. 4), mixing with the contents of the first vessel 15, then breaking through seal 7 and emptying its contents into vessel 20.
  • the number of independent compartments is related to the number of required reagent additions and incubation steps.
  • One vessel or a plurality of vessels could be used and the mixing of reagents controlled using the principles of nodules and grooves as previously described.
  • the collection device holder is turned to the right and then back and forth to mix the contents of vessel 20 through the simultaneous turning of the collection device tip.
  • the collection device holder 14 is turned to the right and thus aligning nodule 4 (FIG. 3) with groove 3 (FIG. 2) and then manually forced downward until the movement of nodule 4 is stopped by the groove end 21 (FIG. 2).
  • the lower portion 10 may be physically one piece with the cylindrical tube 13 or an attached separate piece.
  • the nodule 4 is in contact with the groove end 21, then the collection device tip 5 is in contact with the prefilter membrane 25 through the window 11.
  • the reactants flow through the prefilter membrane through holes 24 of adhesive tape 23 which holds the prefilter membrane 25 against window 11.
  • the shape of the lower portion 10 is configured to enhance contact of the collection device tip with the prefilter or reaction membranes.
  • the prefilter could be placed on the inside wall of the window 11.
  • the reactants flow through holes 21 and 22 of adhesive tape 20 which holds membranes 18 and 19 respectively in place.
  • the holes 21 and 22 restrict the flow of the reactants through a capture membrane 19 and a control membrane 18 and enhances the signal of the reaction by concentrating the labelled ligand or receptor binding pairs into a small area.
  • Absorbant 17 absorbs excess fluid diffusing through the membranes. When an appropriate volume of fluid has diffused through the membranes, usually by saturation of the absorbant, the capture and control membranes are visualized within the holes 21 and 22 respectively by lifting the tab 28 of the adhesive tape 12.
  • Adhesive tape 12 holds the absorbant in place and applies the necessary pressure to ensure diffusion of fiuid through the various layers of the ligand receptor test area.
  • the color intensity of the capture membrane 18 is compared to the color intensity of the control membrane 19.
  • a positive result is determined by visualizing a more intense color in the capture membrane than in the control membrane.
  • a negative result is determined by visualizing no significant color or the same weak color in the capture and control membranes.
  • competitive inhibition assays the positive and negative results are reversed.
  • the size of the ring of color in a single larger capture membrane is related to the concentration of drug in the test sample.
  • Capture membranes can be coated with antigen or antibody or other complementary ligands or receptors and can be used to determine the presence of different antigens or antibodies.
  • the number of vessels used in the apparatus are dependent upon the type of assay and can contain diluents, media for growth amplification of microorganisms, lyophilized labelled ligands or receptors, etc.
  • the seal 7 (FIG. 4) may be attached to two vessels simultaneously or may be independent. Therefore the vessels could be attached to each other or independent.
  • the following example is illustrative:
  • Group C phage associated lysin enzyme which is effective in fragmenting and solubilizing the Group A streptococcal polysaccharide was diluted in a buffer of, 0.05M Citrate phosphate pH 6.1 containing 0.005M EDTA, 0.005M DTT, 0.1% rabbit IgG, 0.05% sodium azide and mixed with Rabbit anti Streptococcal Group A coated gold sol particles (OD518 1.5) diluted in a buffer of 0.02M Tris pH 8.2 containing 1.0% BSA, 0.2% sodium heparin, 0.5% n acetylglucosamine and 0.02% sodium azide in a ratio of 3 parts lysin reagent to 1 part antibody gold sol reagent.
  • the combined reagent was sterile filtered through a 0.2 micron cellulose acetate filter and 200 microliters were aliquoted into acrylic walled reaction cup vessels, having an aluminum foil sealed bottom. The aliquots were frozen and lyophilized. The reaction cup vessels were sealed with aluminum foil and contact cement under nitrogen. Another reaction vessel was cemented to the aluminum foil lid of the first vessel. Two hundred microliters of distilled water was added to the second vessel and then cemented and sealed with aluminum foil. The vessels were placed and positioned into the cylindrical tube. The ligand receptor area was prepared by coating nitrocellulose membranes with rabbit anti group A streptococcal antibody for the capture membranes, and normal rabbit immunoglobulin for the control membranes.
  • the membranes were dried and fixed to a diacetate laminate which had 1.5 mm diameter holes for each membrane.
  • a 1.2 micron cellulose acetate prefilter was used to cover the window of the lower portion of the device.
  • a dacron tipped swab was seeded with varying concentrations of group A streptococci. The swab was placed into the cylindrical tube and forced downward to break the first two seals on the reaction vessels. The swab incubated for 4 minutes at room temperature allowing the lysin enzyme to solubilize the Group A streptococcal polysaccharide and the reaction of the gold labelled anti Group A antibody to form complexes with the released polysaccharide.

Abstract

A device for a self contained solid phase immunodiffusion assay. The device is comprised of a sample collector, a tube with compartmentalized reagents and a ligand receptor capture membrane filter area. The seals can be broken through pressure on the sample collector. The sample collector is pushed through the seals, mixed with reagent, and then pushed into a ligand receptor reaction area wherein the tip of the sample collector contacts diffusable membranes or filters and transfers the reactants to a capture membrane wherein a ligand receptor reaction can be visualized by the naked eye.

Description

BACKGROUND OF THE INVENTION
In order to determine the condition of a patient, and to minimize the diseased state, the need for a rapid diagnosis and appropriate treatment by health care professionals is apparent. Diagnosis of many conditions can be facilitated through the determination or quantitation of antibodies, antigens, nucleotide fragments, and analytes from a biological specimen, which are indicative of a particular disease state or condition. A rapid, sensitive, specific, and simplistic assay is extremely useful for emergency situations, field testing, physicians offices and in home diagnostics. As diagnostic tests become more simple and easier to perform, they are being performed away from the professional clinical laboratory setting to physicians offices and even to the home, where untrained or poorly trained individuals perform the tests usually following product insert instructions alone. These assays are useful provided they are performed properly and are safe to handle for the user. Assays that require multiple steps, have multiple reagents, and have limited storage conditions are prone to misuse, especially if they are performed by individuals without adequate training or skills.
Many types of ligand receptor assays have been developed and commercialized. These assays are less expensive if capital equipment can be eliminated, such as scintillation counters, fluorometers, and colorimeters in the case of radioimmunoassay, fluorescent immunoassay, and enzyme immunoassay respectively. Non instrumental assays, such as latex agglutination, enzyme immunoassays on strips, tubes, membranes or filters have increased the usefulness and ease of performance of immunodiagnostic testing, but are still cumbersome requiring washing steps, multiple reagent additions and usually refrigerated storage conditions.
In some assays amplification or growth of viruses and bacteria are desirable before testing to increase the sensitivity of detection. In other assays adsorption steps to remove interferring substances or inhibitors of the ligand receptor assay, or long incubation of reagents are necessary to perform an assay. Each step for an assay increases the difficulty of testing for the minimally trained individual and any device that would reduce user error would improve diagnostic testing.
Horrisberger et al (J. Histo Cytochem volume 25: 295-305, 1977) described the use of colloidal gold particles in an immunoassay. Leuvering in U.S. Pat. No. 4,313,734 also describe such an immunoassay. Cerny in U.S. patent application Ser. No. 850,253 describes a solid phase immunodiffusion assay using gold sol particles as an immunolabel which can be visualized by the naked eye on a capture membrane, and requires no washing step. Bernstein et al (86th annual American Society for Microbiology Meeting, 1986) presented and described a rapid immunodiffusion enzyme labeled antibody assay for Group A Streptococci on a membrane in which there is no washing step. Gould and Zuk in U.S. Pat. No. 4,552,839 describe the use of colored or dyed beads in a solid phase immunoassay. Through the introduction of colored immunolabelled binding reagents (i.e. gold sol particles, dyed particles, dye encapsulated liposomes, etc.) and the removal of washing steps it becomes possible to perform receptor ligand assays in a closed system with the sequential additions of all reagents within that system.
A number of antigens of interest in the diagnosis of infectious disease are collected with a sterile swab on a shaft to remove the organisms from the suspected infected area or test site (wounds, lesions, blood, tissues, pus, fluids, etc.). The swab is generally used to transfer organisms to a suitable media for culturing which may take as long as 48 hours for growth of bacteria, and 2 weeks for viruses. If the organisms are viable and do grow, then their identification could be made by biochemical, morphological or immunological methods. This time consuming method is slowly becoming replaced by more rapid immunological testing methods or DNA probe methodologies.
In many immunoassays that utilize a swab for collection of antigens or cells, the swab is placed in a solution to release the antigenic materials or cells after collection. It may be necessary to use enzymes, acids, detergents, etc. to solubilize or breakdown the antigens to expose antigenic determinants. The extracted material can then be used in an immunoassay by removing the fluid from the swab and mixing it with other reagents or adding the other reagents directly to the swab extract. In the case where membranes or filters are used to capture the immunoreactants, it is necessary to bring the fluid containing the immunoreactants in contact with the filter or membrane.
In addition, where extraneous cells or debris may interfere with an assay, it may be necessary to have a prefilter (larger pore size filter or membrane) present between the swab and the capture membrane or capture filter to retain these unwanted components.
In some assays, where antigen expression may be low, amplification can be achieved if the organisms are first cultured and then tested. If the culturing and the testing could be performed in a single device, then testing would be simplified. In some assays where there are inhibitors, cross reactive products, or clotting factors, red blood cells, etc., it may be necessary to add adsorbant materials (i.e. beads, kaolin, antibody coated particles, antigen coated particles, or lectin coated particles), anticoagulants, or buffers etc. before the ligand receptor assay can be performed.
It is therefore an object of the present invention to provide a novel test device that utilizes a swab or swab-like material (a shaft with a porous or fibrous absorbant material at one end) to collect a sample and to be able to react the swab with all the necessary reagents which are included within the device, and then to use the swab to transfer the reactants sequentially to other reactants if necessary, and finally to a reaction zone where the specific labelled reactant can be captured and visualized.
It is a further object of the present invention to provide a test device useful in performing ligand receptor assays to detect antigens, haptens, antibodies, DNA or RNA fragments, wherein the user is not required to dispense any of the reagents.
It is a particular object of the present invention to provide a test device that can be stored at nonrefrigerated temperatures, and can be utilized to perform an assay on a biological specimen or fluid without any additional reagents having to be provided to the test device.
In addition it is a further object of the present invention to provide a test device which can utilize lyophilized reagents that can be reconstituted in situ within the device.
BRIEF DESCRIPTION OF THE INVENTION
The present invention maximizes the safety and ease of performance of ligand receptor assays through the use of an apparatus designed to enable a biological specimen to be obtained by a collection device comprising a shaft and an attached adsorbant or absorbant porous or fibrous material (i.e. rayon, dacron, cotton swab) which is inserted into a cylindrical tube. The cylindrical tube contains a sealed vessel or plurality of sealed vessels in sequential order and which the seal will break away or collapse when pressure of the collection device (swab) is exerted on the seal by physically pushing the collection device into and through each vessel. These sealed vessels may contain media, extraction reagents, diluents, labelled antibodies, labelled antigens, labelled lectins,anticoagulants, adsorbants, inactivators, etc. which mix with the biological specimen collected on the collection device. The reagents in these vessels may be lyophilized, enabling long term storage at non refrigerated temperature. The vessels are fixed in position in the cylindrical tube to enable the seals to be broken when physical pressure is exerted on the shaft of the collection device. The collection device holder has appropriate stop points to allow for the collection device tip to enter the appropriate vessel and mix with its contents. A key feature of the vessels are that the tip and shaft of the collecting device can pass through each of the vessels into a lower portion of the cylindrical tube and an attached lower portion comprising a ligand receptor reaction area. The ligand receptor area is comprised of a capture membrane or a filter that will allow unbound reactants to pass through by diffusion and retain the appropriate labelled members of the binding pair. The capturing membrane or filter may be coated with a member of the binding pair to capture the reactants. If capture particles are used, then the capture filter is utilized to retain the particles and allow unbound free labelled antigen or antibody to diffuse through. A prefilter may be used between the collector tip and the capture or filter to remove any nonspecific binding due to debris. An additional absorbant material can be placed behind the capture membrane to increase the uptake of fluid. In either case a specific volume of reactant can be absorbed by controlling the size of the filters and absorbant materials. The configuration of the lower portion allows the collection device to come into physical contact with the prefilter, capture membrane or capture filter.
DESCRIPTION OF THE DRAWINGS
FIG. 1 is a cross sectional view of the invention showing the collection device holder, the collection device, the tube, the sealed reagent compartments and the lower ligand receptor transfer area.
FIG. 2 is a perspective view of the basic structure of the collection device holder and collection device including the grooves for guiding the movement of the collection device through the apparatus.
FIG. 3 is a perspective view of the basic structure of the tube, its compartmentalized reagents, and the nodule which fits into the groove of the collection device holder.
FIG. 4 is a perspective view of the sealed compartments (i.e. vessels) of the apparatus.
FIG. 5 is a cross sectional side view of the lower portion of the apparatus showing the final position of the collection device tip at the window of the ligand receptor area.
FIG. 6 is an exploded perspective view of the ligand receptor test area.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
In the following description, the apparatus and the method will be described in exemplary terms only, for an antigen determining immunoassay test. This discussion, however, is simply to illustrate the structure and use of the apparatus and the technique and steps of the method. The apparatus clearly can be used for any ligand receptor assay in which washing steps have been eliminated and transfer of reactants to or through a porous membrane or filter is used. The best mode, as described hereinafter, is accordingly, to be considered exemplary and not limiting as to the scope and concept of the invention.
Referring first to FIG. 1 for a general depiction of the apparatus, the inventive apparatus comprises a collection device holder 14 which is comprised of a restrictive portion 1 that hold the shaft of the collection device 2 in place, a cylindrical tube 13 which is comprised of one or more sealed reagent compartments 15 and 20, and a lower ligand receptor reaction area 10.
Referring to FIG. 2, the collection device holder 14 has a nodule 16 which positions onto the cylindrical tube and prevents the apparatus from being accidentally opened. When a sample is to be taken, the collection device holder is removed and separated from the cylindrical tube by twisting and pulling up on the collection device holder. This frees up the collection device holder which is then used to collect the test sample (i.e. throat swab, pus, blood, urethral swab, etc.) by allowing the collection device tip 5 to come in contact with the suspect tissue, fluid, wound, etc.
Referring to FIG. 2 and FIG. 3, after obtaining a test sample, the collection device holder is replaced onto the cylindrical tube 13 and turned until the nodule 4 (FIG. 3) on the cylindrical tube is in alignment with the groove 18. The collection device holder is then manually forced downward until the nodule 4 stops at the horizontal groove 19. When the nodule 4 is in contact with horizontal groove 19, then simultaneously the tip 5 will have broken through the first seal (FIG. 4), mixing with the contents of the first vessel 15, then breaking through seal 7 and emptying its contents into vessel 20. The number of independent compartments is related to the number of required reagent additions and incubation steps. One vessel or a plurality of vessels could be used and the mixing of reagents controlled using the principles of nodules and grooves as previously described. In the preferred embodiment, the collection device holder is turned to the right and then back and forth to mix the contents of vessel 20 through the simultaneous turning of the collection device tip.
Referring to FIG. 2 and FIG. 3, after an appropriate incubation time, the collection device holder 14 is turned to the right and thus aligning nodule 4 (FIG. 3) with groove 3 (FIG. 2) and then manually forced downward until the movement of nodule 4 is stopped by the groove end 21 (FIG. 2). Referring to FIG. 5 and FIG. 6 the lower portion 10 may be physically one piece with the cylindrical tube 13 or an attached separate piece. When the nodule 4 is in contact with the groove end 21, then the collection device tip 5 is in contact with the prefilter membrane 25 through the window 11. The reactants flow through the prefilter membrane through holes 24 of adhesive tape 23 which holds the prefilter membrane 25 against window 11. The shape of the lower portion 10 is configured to enhance contact of the collection device tip with the prefilter or reaction membranes. If preferred, the prefilter could be placed on the inside wall of the window 11. In any case, the reactants flow through holes 21 and 22 of adhesive tape 20 which holds membranes 18 and 19 respectively in place. The holes 21 and 22 restrict the flow of the reactants through a capture membrane 19 and a control membrane 18 and enhances the signal of the reaction by concentrating the labelled ligand or receptor binding pairs into a small area. Absorbant 17 absorbs excess fluid diffusing through the membranes. When an appropriate volume of fluid has diffused through the membranes, usually by saturation of the absorbant, the capture and control membranes are visualized within the holes 21 and 22 respectively by lifting the tab 28 of the adhesive tape 12. Adhesive tape 12 holds the absorbant in place and applies the necessary pressure to ensure diffusion of fiuid through the various layers of the ligand receptor test area. The color intensity of the capture membrane 18 is compared to the color intensity of the control membrane 19. A positive result is determined by visualizing a more intense color in the capture membrane than in the control membrane. A negative result is determined by visualizing no significant color or the same weak color in the capture and control membranes. In competitive inhibition assays the positive and negative results are reversed. In the performance of drug analyte assays, the size of the ring of color in a single larger capture membrane is related to the concentration of drug in the test sample. The design of the ligand receptor area, the coating of reagents on the membranes, and the addition or deletion of capture or control membranes are dependent on the particular type of assay being performed. Capture membranes can be coated with antigen or antibody or other complementary ligands or receptors and can be used to determine the presence of different antigens or antibodies. The number of vessels used in the apparatus are dependent upon the type of assay and can contain diluents, media for growth amplification of microorganisms, lyophilized labelled ligands or receptors, etc. The seal 7 (FIG. 4) may be attached to two vessels simultaneously or may be independent. Therefore the vessels could be attached to each other or independent. The following example is illustrative:
EXAMPLE 1 A RAPID IMMUNODIAGNOSTIC TEST FOR GROUP A STREPTOCOCCI
Group C phage associated lysin enzyme which is effective in fragmenting and solubilizing the Group A streptococcal polysaccharide was diluted in a buffer of, 0.05M Citrate phosphate pH 6.1 containing 0.005M EDTA, 0.005M DTT, 0.1% rabbit IgG, 0.05% sodium azide and mixed with Rabbit anti Streptococcal Group A coated gold sol particles (OD518 1.5) diluted in a buffer of 0.02M Tris pH 8.2 containing 1.0% BSA, 0.2% sodium heparin, 0.5% n acetylglucosamine and 0.02% sodium azide in a ratio of 3 parts lysin reagent to 1 part antibody gold sol reagent. The combined reagent was sterile filtered through a 0.2 micron cellulose acetate filter and 200 microliters were aliquoted into acrylic walled reaction cup vessels, having an aluminum foil sealed bottom. The aliquots were frozen and lyophilized. The reaction cup vessels were sealed with aluminum foil and contact cement under nitrogen. Another reaction vessel was cemented to the aluminum foil lid of the first vessel. Two hundred microliters of distilled water was added to the second vessel and then cemented and sealed with aluminum foil. The vessels were placed and positioned into the cylindrical tube. The ligand receptor area was prepared by coating nitrocellulose membranes with rabbit anti group A streptococcal antibody for the capture membranes, and normal rabbit immunoglobulin for the control membranes. The membranes were dried and fixed to a diacetate laminate which had 1.5 mm diameter holes for each membrane. A 1.2 micron cellulose acetate prefilter was used to cover the window of the lower portion of the device. A dacron tipped swab was seeded with varying concentrations of group A streptococci. The swab was placed into the cylindrical tube and forced downward to break the first two seals on the reaction vessels. The swab incubated for 4 minutes at room temperature allowing the lysin enzyme to solubilize the Group A streptococcal polysaccharide and the reaction of the gold labelled anti Group A antibody to form complexes with the released polysaccharide. After four minutes the swab was forced downward through the third seal into the lower portion, coming in contact with the ligand receptor area. The fluid diffused through the prefilter into capture and control membranes. After 30 seconds the tab of the ligand receptor area was pulled away from the lower portion and visuallized. A distinct color reaction with 2×103 organisms of Group A streptococci could be distinguished in the capture membrane compared to the colorless control membrane.
The foregoing disclosure and the showing made in the drawings are merely illustrative of the principles of this invention and are not to be interpreted in a limiting sense. It is understood that through the example and embodiments described herein, that various modifications in light thereof will be suggested to persons skilled in the art to be included in the spirit and review of this application and the scope of the approved claims.

Claims (13)

What is claimed is:
1. A self-contained ligand receptor assay device, the combination comprising;
(a) collection means having an elongated shaft with an absorbent tip for collecting a specimen;
(b) a tube, cooperative with said collection means, said tube having an interior, an open end and a distal end;
(c) at least one sealed chamber in said tube;
(d) a number of reagents equal to the number of said at least one chamber located one reagent in each of said at least one chamber;
(e) means to seal each said reagent in a respective one of said at least one chamber;
(f) said seal means comprising frangible seals;
(g) ligand receptor reaction means including at least one porous membrane;
(h) means forming a hole in said tube in predetermined spaced relation to said distal end thereof;
(i) means fixing said ligand receptor reaction means to said tube covering said hole with said least one porous membrane exposed to said interior of said tube; and
(j) the length of said shaft being such as to permit said absorbent tip to reach through all of said at least one chamber to mix all of said at least one reagent and to permit fluid diffusion between said tip and said at least one membrane; whereby
(k) a labelled ligand or a labelled receptor is immobilized on said ligand receptor reaction means and the result of said assay can be examined.
2. The device of claim 1, further comprises a guiding mechanism for said collection means, said guiding mechanism comprising guide and stop means, nodule means on said tube, and said guide and stop means and said nodule means cooperating with each other causing sequential breaking of said at least one frangible seal and moving said absorbent tip completely through and out of said at least one chamber when said absorbent tip passes through all of said at least one chamber.
3. The device of claim 1, wherein said absorbent tip for collecting a specimen is sterile.
4. The device of claim 1, wherein said at least one porous membrane comprises a plurality of porous membranes at least one membrane of which is coated with different ligands or receptors.
5. The device of claim 1, wherein said at least one reagent comprises a labelled ligand or a labelled receptor.
6. The device of claim 5, wherein said labelled ligand or labelled receptor reagent is lyophilized.
7. The device of claim 5, further comprising at least one other chamber, and microbiological growth media in said other chamber.
8. The device of claim 5, further comprising at least one other chamber, and an extraction reagent for exposing antigenic determinants or hidden epitopes of an antigen, in said other chamber.
9. The device of claim 5, further comprising at least one other chamber, adsorption particles in said other chamber, said absorption particles comprising binders to remove inhibiting or cross reative substances from said assay; and at least one other porous membrane, and
(a) said adsorption particles being larger than said labelled ligands or labelled receptors, and
(b) said at least one other porous membrane having an effective pore size smaller than said adsorption particles and larger than said labelled ligands or labelled receptors.
10. The device of claim 5, wherein one said at least one chamber contains ligand or receptor coated particles which are larger in mean particle size diameter than said labelled ligand or labelled receptor and the effective pore size of said at least one porous membrane.
11. The device of claim 5 wherein said labelled ligand or labelled receptor reagent comprised a chromophore.
12. The device of claim 11 wherein said chromophore is selected from the group consisting of dyes, dyed particles, pigments, metal sol particles, or dye encapsulated liposomes.
13. The device of claim 12, wherein said chromophore is a metal sol particle selected from the group consisting of gold, silver, or the combination of gold and silver.
US06/938,003 1986-12-03 1986-12-03 Device for self contained solid phase immunodiffusion assay Expired - Lifetime US4770853A (en)

Priority Applications (8)

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US06/938,003 US4770853A (en) 1986-12-03 1986-12-03 Device for self contained solid phase immunodiffusion assay
EP88900311A EP0293447B1 (en) 1986-12-03 1987-12-01 A device and method for self contained solid phase immunodiffusion assay
AT88900311T ATE110852T1 (en) 1986-12-03 1987-12-01 DEVICE AND METHOD FOR SOLID PHASE IMMUNODIFFUSION STUDY.
AU10518/88A AU1051888A (en) 1986-12-03 1987-12-01 A device and method for self contained solid phase immunodiffusion assay
PCT/US1987/003169 WO1988004431A1 (en) 1986-12-03 1987-12-01 A device and method for self contained solid phase immunodiffusion assay
JP63500684A JPH01502054A (en) 1986-12-03 1987-12-01 Apparatus and method for self-contained solid-phase immunodiffusion assays
DE3750473T DE3750473T2 (en) 1986-12-03 1987-12-01 DEVICE AND METHOD FOR SOLID-PHASE IMMUNODIFFUSION EXAMINATION.
US07/818,439 US5169789A (en) 1986-12-03 1991-12-27 Device and method for self contained solid phase immunodiffusion assay

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US06/938,003 US4770853A (en) 1986-12-03 1986-12-03 Device for self contained solid phase immunodiffusion assay

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EP (1) EP0293447B1 (en)
JP (1) JPH01502054A (en)
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Cited By (135)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4876068A (en) * 1989-03-03 1989-10-24 Chemetrics, Inc. Test kit for colorimetric analysis
US4920057A (en) * 1989-03-03 1990-04-24 Chemetrics, Inc. Method for colorimetric analysis of metals
WO1990008954A1 (en) * 1989-02-02 1990-08-09 Hybrivet Systems, Inc. Test swab and methods of making and using same
US4948561A (en) * 1989-02-09 1990-08-14 Eastman Kodak Company Multiple level filter device and kit containing same
US4963325A (en) * 1988-05-06 1990-10-16 Hygeia Sciences, Inc. Swab expressor immunoassay device
US4978504A (en) * 1988-02-09 1990-12-18 Nason Frederic L Specimen test unit
US5039618A (en) * 1989-02-02 1991-08-13 Hybrivet Systems, Inc. Test swab cartridge type device and method for detecting lead and cadmium
US5078968A (en) * 1988-02-09 1992-01-07 Nason Frederic L Specimen test unit
US5116576A (en) * 1987-12-08 1992-05-26 Scientific Generics Limited Device for analytical determinations
US5120503A (en) * 1989-07-14 1992-06-09 Eastman Kodak Company Extracting device for extracting antigens
US5160704A (en) * 1989-02-17 1992-11-03 Remedia Ag Method and apparatus for collecting and separating particles from fluid for medical diagnosis
US5212067A (en) * 1989-03-30 1993-05-18 The United States Of America As Represented By The Secretary Of Agriculture Quick assay for detection of salmonella
US5238649A (en) * 1988-02-09 1993-08-24 Nason Frederic L Specimen test unit
US5252496A (en) * 1989-12-18 1993-10-12 Princeton Biomeditech Corporation Carbon black immunochemical label
US5256537A (en) * 1991-12-11 1993-10-26 Becton, Dickinson And Company Culturette safety sleeve
US5260031A (en) * 1990-12-18 1993-11-09 Saliva Diagnostic Systems, Inc. Saliva sampling device with sample adequacy indicating system
US5266266A (en) * 1988-02-09 1993-11-30 Nason Frederic L Specimen test unit
US5268148A (en) * 1990-12-18 1993-12-07 Saliva Diagnostic Systems, Inc. Saliva sampling device and sample adequacy system
US5278075A (en) * 1989-02-02 1994-01-11 Hybrivet Systems, Inc. Test swab to detect a substance on a surface and method of making and using same
US5288648A (en) * 1989-12-01 1994-02-22 Sangstat Medical Corporation Multiwell stat test
US5362654A (en) * 1984-07-20 1994-11-08 Sangstat Medical Corporation Self-contained quantitative assay
US5364792A (en) * 1989-02-02 1994-11-15 Hybrivet Systems, Inc. Test swab and method of making and using same
US5384097A (en) * 1993-07-23 1995-01-24 Brouwer; Emilio A. Specimen container
US5393496A (en) * 1990-12-18 1995-02-28 Saliva Diagnostic Systems, Inc. Saliva sampling device and sample adequacy system
US5427739A (en) * 1992-08-27 1995-06-27 Schering-Plough Healthcare Products, Inc. Apparatus for performing immunoassays
US5429952A (en) * 1988-02-02 1995-07-04 Biocode, Inc. Marking of products to establish identity and source
WO1995019447A1 (en) * 1994-01-14 1995-07-20 The Jockey Club Non-invasive sampling method for nucleic acid analysis
US5531966A (en) * 1993-07-23 1996-07-02 Brouwer; Emilio A. Specimen container
US5550061A (en) * 1989-02-02 1996-08-27 Hybrivet Systems, Inc. Test swab and method of using same
US5591645A (en) * 1987-03-27 1997-01-07 Becton, Dickinson & Co. Solid phase chromatographic immunoassay
WO1997003209A1 (en) * 1995-07-12 1997-01-30 Charm Sciences, Inc. Test apparatus, system and method for the detection of test samples
US5714389A (en) * 1988-06-27 1998-02-03 Carter-Wallace, Inc. Test device and method for colored particle immunoassay
US5759847A (en) * 1995-07-14 1998-06-02 Difco Laboratories System and apparatus for automatically transferring media
US5776713A (en) * 1988-02-02 1998-07-07 Biocode Ltd. Marking of products to establish identity and source
US5827675A (en) * 1995-07-12 1998-10-27 Charm Sciences, Inc. Test apparatus, system and method for the detection of test samples
US5869003A (en) * 1998-04-15 1999-02-09 Nason; Frederic L. Self contained diagnostic test unit
US5877028A (en) 1991-05-29 1999-03-02 Smithkline Diagnostics, Inc. Immunochromatographic assay device
US5879635A (en) * 1997-03-31 1999-03-09 Nason; Frederic L. Reagent dispenser and related test kit for biological specimens
US5879951A (en) 1997-01-29 1999-03-09 Smithkline Diagnostics, Inc. Opposable-element assay device employing unidirectional flow
USD408082S (en) * 1997-12-29 1999-04-13 Charm Sciences, Inc. Pocket-size sanitation test kit
US5939252A (en) 1997-05-09 1999-08-17 Lennon; Donald J. Detachable-element assay device
US5942407A (en) * 1996-06-25 1999-08-24 Immunomatrix, Inc. Light-emitting immunoassay
US5958790A (en) * 1984-12-20 1999-09-28 Nycomed Imaging As Solid phase transverse diffusion assay
US5998220A (en) 1991-05-29 1999-12-07 Beckman Coulter, Inc. Opposable-element assay devices, kits, and methods employing them
US6001658A (en) * 1996-09-13 1999-12-14 Diagnostic Chemicals Limited Test strip apparatus and method for determining presence of analyte in a fluid sample
EP1024354A1 (en) * 1997-10-13 2000-08-02 Kikkoman Corporation Sample collecting member and wiping inspection instrument
US6168956B1 (en) 1991-05-29 2001-01-02 Beckman Coulter, Inc. Multiple component chromatographic assay device
US6207113B1 (en) * 1995-02-15 2001-03-27 Wako Pure Chemical Industries, Ltd. Device for sampling feces
WO2001036099A1 (en) * 1999-11-15 2001-05-25 Dipro Diagnostics Handels Gmbh Disposable test device
US6248294B1 (en) 1998-04-15 2001-06-19 Frederic L. Nason Self contained diagnostic test unit
US6274314B1 (en) 1998-04-02 2001-08-14 Nyxis Neurotherapies, Inc. Diagnostic assay for the modified nucleosides pseudouridine, 7-methyladenosine, or 1-methyladenosine
US6319676B1 (en) 1995-05-02 2001-11-20 Carter Wallace, Inc. Diagnostic detection device and method
US6372516B1 (en) 2000-09-07 2002-04-16 Sun Biomedical Laboratories, Inc. Lateral flow test device
US20020136663A1 (en) * 2000-09-08 2002-09-26 Bioavailability Systems, Llc Method for simplified shipping of clinical specimens and optional direct analysis
US20020176806A1 (en) * 2001-03-26 2002-11-28 Weiping Ren Application of a disposable tube in biomedical and immunological assays
US20030013121A1 (en) * 2001-07-12 2003-01-16 Khan Waheed N. Diagnostic test kit
US6565808B2 (en) 2001-05-18 2003-05-20 Acon Laboratories Line test device and methods of use
US20030129738A1 (en) * 2002-01-04 2003-07-10 Sorenson James Levoy System, apparatus, composition and method for non-invasive extraction, secure handling and storage and facile processing and facile processing of a specimen
US20030143752A1 (en) * 2001-12-06 2003-07-31 Biocontrol Systems, Inc. Sample collection and testing system
US20030235518A1 (en) * 2002-06-21 2003-12-25 Shea Laurence R. Array assay devices and methods of using the same
USRE38430E1 (en) * 1987-03-27 2004-02-17 Becton, Dickinson And Company Solid phase chromatographic immunoassay
US6699722B2 (en) 2000-04-14 2004-03-02 A-Fem Medical Corporation Positive detection lateral-flow apparatus and method for small and large analytes
US6703216B2 (en) 2002-03-14 2004-03-09 The Regents Of The University Of California Methods, compositions and apparatuses for detection of gamma-hydroxybutyric acid (GHB)
US6737266B1 (en) * 1999-10-01 2004-05-18 3M Innovative Properties Company Devices and methods for microorganism detection
US20040170536A1 (en) * 2001-03-05 2004-09-02 Victory Daykin Biological specimen collection apparatus
US20040214316A1 (en) * 2003-04-24 2004-10-28 O'connell David Personal cell sampling kit
US20040220748A1 (en) * 2002-04-24 2004-11-04 Biocontrol Systems, Inc. Sample collection and testing system
US20050084842A1 (en) * 2003-10-20 2005-04-21 O'connor Amanda L. Diagnostic test device and method of using same
US6890484B2 (en) 2001-05-18 2005-05-10 Acon Laboratories, Inc. In line test device and methods of use
US20050238535A1 (en) * 2001-10-03 2005-10-27 20/20 Genesystems, Inc. Rapid assay, method and system for detecting biowarfare agents
US20050255533A1 (en) * 2004-02-10 2005-11-17 Brendan Bioscience, Llc Comprehensive food allergy test
US20060093524A1 (en) * 1997-06-20 2006-05-04 Dakocytomation Denmark A/S Device for taking and examining samples
US20060188939A1 (en) * 2005-02-16 2006-08-24 Ping Gao Fecal sample test device and methods of use
US20060240498A1 (en) * 2002-08-13 2006-10-26 Michael Friedman Devices and methods for detecting amniotic fluid in vaginal secretions
US7132249B1 (en) 2003-05-12 2006-11-07 Charm Sciences, Inc. Method of determining allergenic food on surfaces
US20080206740A1 (en) * 2004-12-22 2008-08-28 Skiffington Richard T Sampling Method and Device
US20080254444A1 (en) * 2004-12-16 2008-10-16 Javanbakhsh Esfandiari Immunoassay Devices and Use Thereof
US20080260581A1 (en) * 2004-01-21 2008-10-23 Orion Diagnostica Oy Sampling and Assay Device
US20080299600A1 (en) * 2005-08-02 2008-12-04 Bommarito G Marco Apparatus Assembly and Method for Detecting an Analyte
US20080302192A1 (en) * 2005-08-02 2008-12-11 Gonzalez Bernard A Apparatus and Method For Detecting an Analyte
US20080302193A1 (en) * 2005-08-02 2008-12-11 Bommarito G Marco Apparatus and Method For Detecting an Analyte
WO2008154813A1 (en) 2007-06-15 2008-12-24 Xiamen University Monoclonal antibodies binding to avian influenza virus subtype h5 haemagglutinin and uses thereof
US20090019953A1 (en) * 2005-08-02 2009-01-22 3 Innovative Properties Company Apparatus And Method For Detecting An Analyte
US20090030342A1 (en) * 2007-07-27 2009-01-29 3M Innovative Properties Company Apparatus and method for releasing a sample of material
US20090030341A1 (en) * 2007-07-27 2009-01-29 3M Innovative Properties Company Sample release system
US7494781B1 (en) 2003-05-12 2009-02-24 Charm Sciences, Inc. Sensitive method for detecting low levels of ATP
US20090053694A1 (en) * 2005-12-26 2009-02-26 Kriksunov Leo B Photochemically Amplified Bioassay
US20100047927A1 (en) * 2005-12-16 2010-02-25 Bayer Cropscience K.K. Kit for measurement of termite insecticide active ingredient by immunoassay method
US20100136670A1 (en) * 2007-05-04 2010-06-03 Markovsky Robert J Sampling Method and Device
US7767447B2 (en) 2007-06-21 2010-08-03 Gen-Probe Incorporated Instruments and methods for exposing a receptacle to multiple thermal zones
US20100285572A1 (en) * 2006-05-09 2010-11-11 Salter Robert S Inhibition Assay Method and Device for Detection of Antibiotics
US7919325B2 (en) 2004-05-24 2011-04-05 Authentix, Inc. Method and apparatus for monitoring liquid for the presence of an additive
US20110124022A1 (en) * 2008-07-23 2011-05-26 Diabetomics, Llc Methods for detecting pre-diabetes and diabetes
US20110146419A1 (en) * 2008-02-15 2011-06-23 Gonzalez Bernard A Sample acquisition device
US20110179887A1 (en) * 2008-02-15 2011-07-28 Cobian Paul J Sample acquisition device
US8168396B2 (en) 2009-05-11 2012-05-01 Diabetomics, Llc Methods for detecting pre-diabetes and diabetes using differential protein glycosylation
US8507259B2 (en) 2005-03-11 2013-08-13 Chembio Diagnostics Systems, Inc. Dual path immunoassay device
US8585982B1 (en) * 2012-01-31 2013-11-19 The United States Of America As Represented By The Secretary Of The Navy Field colorimetric test device
US8603835B2 (en) 2011-02-10 2013-12-10 Chembio Diagnostic Systems, Inc. Reduced step dual path immunoassay device and method
WO2014087255A2 (en) 2012-11-21 2014-06-12 Oslo Universitetssykehus Hf Systems and methods for monitoring biological fluids
US20150024384A1 (en) * 2013-07-22 2015-01-22 Kianoosh Peyvan Sequential delivery device and method
US8962341B2 (en) 2008-12-12 2015-02-24 The Commonwealth Medical College Cell-based detection of APF through its interaction with CKAP4 for diagnosis of interstitial cystitis
US20150191690A1 (en) * 2014-01-06 2015-07-09 Lawrence Livermore National Security, Llc Compositions and methods for pathogen transport
US20160121322A1 (en) * 2013-05-24 2016-05-05 Premier Biotech, Inc. Multi-stage oral-fluid testing device
US9446406B2 (en) 2012-06-29 2016-09-20 Biocontrol Systems, Inc. Sample collection and bioluminescent analysis system
WO2016172660A1 (en) 2015-04-23 2016-10-27 Board Of Regents Of The Nevada System Of Higher Education, On Behalf Of The University Of Nevada, Reno Fungal detection using mannan epitope
WO2017023929A1 (en) 2015-08-04 2017-02-09 Cd Diagnostics, Inc. Methods for detecting adverse local tissue reaction (altr) necrosis
WO2017077392A1 (en) 2015-11-06 2017-05-11 Oslo Universitetssykehus Hf Methods and devices for detecting methanol poisoning using formate oxidase
WO2017100454A1 (en) 2015-12-09 2017-06-15 Intuitive Biosciences, Inc. Automated silver enhancement system
US9739773B1 (en) 2010-08-13 2017-08-22 David Gordon Bermudes Compositions and methods for determining successful immunization by one or more vaccines
WO2017147186A1 (en) 2016-02-22 2017-08-31 Ursure, Inc. System and method for detecting therapeutic agents to monitor adherence to a treatment regimen
WO2017180909A1 (en) * 2016-04-13 2017-10-19 Nextgen Jane, Inc. Sample collection and preservation devices, systems and methods
WO2017178554A1 (en) 2016-04-13 2017-10-19 INSERM (Institut National de la Santé et de la Recherche Médicale) Methods and kits for the rapid detection of the escherichia coli o25b-st131 clone
US9833783B1 (en) 2016-12-28 2017-12-05 Neogen Corporation Fluid retainer cartridge assembly and method for utilizing the same
US9885710B2 (en) 2014-04-02 2018-02-06 Chembio Diagnostic Systems, Inc. Immunoassay utilizing trapping conjugate
US9891233B2 (en) 2013-01-02 2018-02-13 N-Dia, Inc. Methods for predicting time-to-delivery in pregnant women
US9903866B2 (en) 2016-04-05 2018-02-27 Conquerab Inc. Portable devices for detection of antibodies against therapeutic drugs
US9927443B2 (en) 2015-04-10 2018-03-27 Conquerab Inc. Risk assessment for therapeutic drugs
US10119968B2 (en) 2012-06-02 2018-11-06 Test Anywhere Technology Self-contained diagnostic test with advanceable test strip
WO2018203145A1 (en) 2017-05-03 2018-11-08 Oslo Universitetssykehus Hf Systems and methods for monitoring biological fluids
EP3415919A1 (en) 2012-02-07 2018-12-19 Intuitive Biosciences Inc. Mycobacterium tuberculosis specific peptides for detection of infection or immunization in non-human primates
EP3418397A1 (en) 2012-01-24 2018-12-26 CD Diagnostics, Inc. System for detecting infection in synovial fluid
EP3425399A1 (en) 2005-03-11 2019-01-09 Chembio Diagnostic Systems, Inc. Dual path immunoassay device
WO2020014353A1 (en) 2018-07-11 2020-01-16 The United States Of America, As Represented By The Secretary, Department Of Health And Human Services Monoclonal antibody for the detection of the antiretroviral drug emtricitabine (ftc, 2',3'-dideoxy-5-fluoro-3'-thiacytidine)
US10656164B2 (en) 2016-12-22 2020-05-19 Qiagen Sciences, Llc Screening asymptomatic pregnant woman for preterm birth
US10690667B2 (en) 2014-10-27 2020-06-23 Chembio Diagnostic Systems, Inc. Rapid screening assay for qualitative detection of multiple febrile illnesses
US20200278368A1 (en) * 2017-09-27 2020-09-03 Axxin Pty Ltd Diagnostic test system and method
US10935555B2 (en) 2016-12-22 2021-03-02 Qiagen Sciences, Llc Determining candidate for induction of labor
USD946751S1 (en) * 2019-08-12 2022-03-22 Siemens Healthcare Diagnostics Inc. Dual-ended swab
US11293839B2 (en) 2018-08-16 2022-04-05 Epitope Biotechnology Co., Ltd. Device for fecal sample collection and extraction
US11300576B2 (en) 2019-01-29 2022-04-12 Arizona Board Of Regents On Behalf Of Arizona State University DARPin reagents that distinguish Alzheimer's disease and Parkinson's disease samples
USD956962S1 (en) * 2019-07-30 2022-07-05 Illinois Tool Works Inc. Swab
DE102021110457A1 (en) 2021-04-23 2022-10-27 SOLIOS DIAGNOSTICS GmbH Method, test device and test kit for performing an assay directed to the detection of an organic structure
US11634758B2 (en) 2012-02-03 2023-04-25 Axxin Pty Ltd Nucleic acid amplification and detection apparatus and method
US20240050955A1 (en) * 2023-03-03 2024-02-15 Ustar Biotechnologies (Hangzhou) Ltd. Multi-functional integrated molecular test cartridge and application thereof

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5103836A (en) * 1990-02-28 1992-04-14 Epitope, Inc. Oral collection device and kit for immunoassay
CA2023636A1 (en) * 1989-09-21 1991-03-22 Andrew S. Goldstein Oral immunoglobulin collection for immunoassay
DK0439917T3 (en) * 1989-12-01 1996-05-28 Sangstat Medical Corp Device for detection and semi-quantitative measurement of analytes
US5415994A (en) * 1993-08-02 1995-05-16 Quidel Corporation Lateral flow medical diagnostic assay device with sample extraction means
CA2163501A1 (en) * 1994-11-28 1996-05-29 Petrus Franciscus Hendrikus Maria Verheijden Sample collection device
EP0724909A1 (en) 1994-11-28 1996-08-07 Akzo Nobel N.V. Sample collection device
US5968746A (en) 1997-11-26 1999-10-19 Schneider; David R. Method and apparatus for preserving human saliva for testing
WO2000009016A1 (en) * 1998-08-14 2000-02-24 Biocontrol Systems, Inc. Detection of contaminants using self-contained devices employing target material binding dyes
US6576460B1 (en) 1999-10-28 2003-06-10 Cornell Research Foundation, Inc. Filtration-detection device and method of use
FR3033047B1 (en) * 2015-02-20 2017-07-14 L'etat Francais Represente Par Le Mini De L'interieur COLLECTION DEVICES FOR THE DIRECT AND INDIRECT FAST ANALYSIS OF NUCLEIC ACIDS FROM BIOLOGICAL TRACES
GB2598614B (en) * 2020-09-04 2022-08-31 I Abra Ltd Sample container
WO2022049386A1 (en) * 2020-09-04 2022-03-10 I-Abra Limited Apparatus and method for analysis, sample container and cap for a sample container
CN113791032B (en) * 2021-09-08 2023-09-01 营口理工学院 Physical parameter testing device and method

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4150950A (en) * 1977-09-28 1979-04-24 Corning Glass Works Transport system for clinical specimens
US4184483A (en) * 1973-05-08 1980-01-22 U.S. Medical Research & Development, Inc. Method of and apparatus for collecting cultures
US4196167A (en) * 1978-12-26 1980-04-01 California Medical Developments, Inc. Drug detection device
US4223093A (en) * 1978-08-25 1980-09-16 Precision Dynamics Corporation Culture collection and transport device
US4224304A (en) * 1978-02-14 1980-09-23 Mitsubishi Chemical Industries, Limited Method and apparatus for the measurement of antigens and antibodies
US4313929A (en) * 1978-02-16 1982-02-02 Mitsubishi Chemical Industries Limited Method of measurement of antigens and antibodies
US4353868A (en) * 1981-05-29 1982-10-12 Sherwood Medical Industries Inc. Specimen collecting device
US4355113A (en) * 1981-06-19 1982-10-19 Mennen Frederick C Over the counter swab kit for self detection of gonorrhea in the male using saline ampule
US4391904A (en) * 1979-12-26 1983-07-05 Syva Company Test strip kits in immunoassays and compositions therein
US4409988A (en) * 1973-05-08 1983-10-18 Donald J. Greenspan Apparatus for collecting cultures

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3960489A (en) * 1974-04-01 1976-06-01 General Electric Company Method and apparatus for determination of concentration of immunologically reactive biological particles
US4235601A (en) * 1979-01-12 1980-11-25 Thyroid Diagnostics, Inc. Test device and method for its use
JPS5934154A (en) * 1982-08-19 1984-02-24 Konishiroku Photo Ind Co Ltd Determination by means of immunoanalytical element
US4673657A (en) * 1983-08-26 1987-06-16 The Regents Of The University Of California Multiple assay card and system
US4703017C1 (en) * 1984-02-14 2001-12-04 Becton Dickinson Co Solid phase assay with visual readout

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4184483A (en) * 1973-05-08 1980-01-22 U.S. Medical Research & Development, Inc. Method of and apparatus for collecting cultures
US4409988A (en) * 1973-05-08 1983-10-18 Donald J. Greenspan Apparatus for collecting cultures
US4150950A (en) * 1977-09-28 1979-04-24 Corning Glass Works Transport system for clinical specimens
US4224304A (en) * 1978-02-14 1980-09-23 Mitsubishi Chemical Industries, Limited Method and apparatus for the measurement of antigens and antibodies
US4313929A (en) * 1978-02-16 1982-02-02 Mitsubishi Chemical Industries Limited Method of measurement of antigens and antibodies
US4223093A (en) * 1978-08-25 1980-09-16 Precision Dynamics Corporation Culture collection and transport device
US4196167A (en) * 1978-12-26 1980-04-01 California Medical Developments, Inc. Drug detection device
US4391904A (en) * 1979-12-26 1983-07-05 Syva Company Test strip kits in immunoassays and compositions therein
US4353868A (en) * 1981-05-29 1982-10-12 Sherwood Medical Industries Inc. Specimen collecting device
US4355113A (en) * 1981-06-19 1982-10-19 Mennen Frederick C Over the counter swab kit for self detection of gonorrhea in the male using saline ampule

Cited By (228)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5362654A (en) * 1984-07-20 1994-11-08 Sangstat Medical Corporation Self-contained quantitative assay
US5958790A (en) * 1984-12-20 1999-09-28 Nycomed Imaging As Solid phase transverse diffusion assay
USRE38430E1 (en) * 1987-03-27 2004-02-17 Becton, Dickinson And Company Solid phase chromatographic immunoassay
US5591645A (en) * 1987-03-27 1997-01-07 Becton, Dickinson & Co. Solid phase chromatographic immunoassay
US5116576A (en) * 1987-12-08 1992-05-26 Scientific Generics Limited Device for analytical determinations
US5429952A (en) * 1988-02-02 1995-07-04 Biocode, Inc. Marking of products to establish identity and source
US5776713A (en) * 1988-02-02 1998-07-07 Biocode Ltd. Marking of products to establish identity and source
US4978504A (en) * 1988-02-09 1990-12-18 Nason Frederic L Specimen test unit
US5238649A (en) * 1988-02-09 1993-08-24 Nason Frederic L Specimen test unit
US5266266A (en) * 1988-02-09 1993-11-30 Nason Frederic L Specimen test unit
US5078968A (en) * 1988-02-09 1992-01-07 Nason Frederic L Specimen test unit
US4963325A (en) * 1988-05-06 1990-10-16 Hygeia Sciences, Inc. Swab expressor immunoassay device
US6485982B1 (en) 1988-06-27 2002-11-26 Armkel, Llc Test device and method for colored particle immunoassay
US5989921A (en) * 1988-06-27 1999-11-23 Carter Wallace, Inc. Test device and method for colored particle immunoassay
US5714389A (en) * 1988-06-27 1998-02-03 Carter-Wallace, Inc. Test device and method for colored particle immunoassay
US5550061A (en) * 1989-02-02 1996-08-27 Hybrivet Systems, Inc. Test swab and method of using same
WO1990008954A1 (en) * 1989-02-02 1990-08-09 Hybrivet Systems, Inc. Test swab and methods of making and using same
US5278075A (en) * 1989-02-02 1994-01-11 Hybrivet Systems, Inc. Test swab to detect a substance on a surface and method of making and using same
US5039618A (en) * 1989-02-02 1991-08-13 Hybrivet Systems, Inc. Test swab cartridge type device and method for detecting lead and cadmium
US5364792A (en) * 1989-02-02 1994-11-15 Hybrivet Systems, Inc. Test swab and method of making and using same
US5330917A (en) * 1989-02-02 1994-07-19 Hybrivet Systems, Inc. Test swab device and method of detecting lead, mercury, arsenic, and bismuth
US4948561A (en) * 1989-02-09 1990-08-14 Eastman Kodak Company Multiple level filter device and kit containing same
US5160704A (en) * 1989-02-17 1992-11-03 Remedia Ag Method and apparatus for collecting and separating particles from fluid for medical diagnosis
US4876068A (en) * 1989-03-03 1989-10-24 Chemetrics, Inc. Test kit for colorimetric analysis
US4920057A (en) * 1989-03-03 1990-04-24 Chemetrics, Inc. Method for colorimetric analysis of metals
US5212067A (en) * 1989-03-30 1993-05-18 The United States Of America As Represented By The Secretary Of Agriculture Quick assay for detection of salmonella
US5120503A (en) * 1989-07-14 1992-06-09 Eastman Kodak Company Extracting device for extracting antigens
US5288648A (en) * 1989-12-01 1994-02-22 Sangstat Medical Corporation Multiwell stat test
US5252496A (en) * 1989-12-18 1993-10-12 Princeton Biomeditech Corporation Carbon black immunochemical label
US6506612B2 (en) 1989-12-18 2003-01-14 Princeton Biomeditech Corporation Immunoassay devices and materials
US6737277B1 (en) 1989-12-18 2004-05-18 Pmb-Selfcare Llc Immunoassay devices and materials
US6027943A (en) * 1989-12-18 2000-02-22 Princeton Biomeditech Corporation Immunoassay devices and materials
US5559041A (en) * 1989-12-18 1996-09-24 Princeton Biomeditech Corporation Immunoassay devices and materials
US6541277B1 (en) 1989-12-18 2003-04-01 Princeton Biomeditech Corporation Immunoassay devices and materials
US5728587A (en) * 1989-12-18 1998-03-17 Pmb-Selfcare, Llc Immunoassay devices and materials
US5283038A (en) * 1990-12-18 1994-02-01 Saliva Diagnostic Systems, Inc. Fluid sampling and testing device
US5268148A (en) * 1990-12-18 1993-12-07 Saliva Diagnostic Systems, Inc. Saliva sampling device and sample adequacy system
US5393496A (en) * 1990-12-18 1995-02-28 Saliva Diagnostic Systems, Inc. Saliva sampling device and sample adequacy system
US5260031A (en) * 1990-12-18 1993-11-09 Saliva Diagnostic Systems, Inc. Saliva sampling device with sample adequacy indicating system
US6168956B1 (en) 1991-05-29 2001-01-02 Beckman Coulter, Inc. Multiple component chromatographic assay device
US6017767A (en) 1991-05-29 2000-01-25 Beckman Coulter, Inc. Assay device
US5998220A (en) 1991-05-29 1999-12-07 Beckman Coulter, Inc. Opposable-element assay devices, kits, and methods employing them
US5877028A (en) 1991-05-29 1999-03-02 Smithkline Diagnostics, Inc. Immunochromatographic assay device
US5425915A (en) * 1991-12-11 1995-06-20 Becton Dickinson And Company Culturette safety sleeve
US5256537A (en) * 1991-12-11 1993-10-26 Becton, Dickinson And Company Culturette safety sleeve
US5427739A (en) * 1992-08-27 1995-06-27 Schering-Plough Healthcare Products, Inc. Apparatus for performing immunoassays
US5531966A (en) * 1993-07-23 1996-07-02 Brouwer; Emilio A. Specimen container
US5384097A (en) * 1993-07-23 1995-01-24 Brouwer; Emilio A. Specimen container
WO1995019447A1 (en) * 1994-01-14 1995-07-20 The Jockey Club Non-invasive sampling method for nucleic acid analysis
US6207113B1 (en) * 1995-02-15 2001-03-27 Wako Pure Chemical Industries, Ltd. Device for sampling feces
US6767714B2 (en) 1995-05-02 2004-07-27 Armkel, Llc Diagnostic detection device and method
US20040171174A1 (en) * 1995-05-02 2004-09-02 Albert Nazareth Diagnostic detection device and method
US6319676B1 (en) 1995-05-02 2001-11-20 Carter Wallace, Inc. Diagnostic detection device and method
US7045342B2 (en) 1995-05-02 2006-05-16 Church & Dwight Co., Inc. Diagnostic detection device and method
US5965453A (en) * 1995-07-12 1999-10-12 Charm Sciences, Inc. Test apparatus, system and method for the detection of test samples
US5827675A (en) * 1995-07-12 1998-10-27 Charm Sciences, Inc. Test apparatus, system and method for the detection of test samples
WO1997003209A1 (en) * 1995-07-12 1997-01-30 Charm Sciences, Inc. Test apparatus, system and method for the detection of test samples
US6180395B1 (en) * 1995-07-12 2001-01-30 Charm Sciences, Inc. Reagent chamber for test apparatus and test apparatus
US5759847A (en) * 1995-07-14 1998-06-02 Difco Laboratories System and apparatus for automatically transferring media
US5942407A (en) * 1996-06-25 1999-08-24 Immunomatrix, Inc. Light-emitting immunoassay
US6001658A (en) * 1996-09-13 1999-12-14 Diagnostic Chemicals Limited Test strip apparatus and method for determining presence of analyte in a fluid sample
US5879951A (en) 1997-01-29 1999-03-09 Smithkline Diagnostics, Inc. Opposable-element assay device employing unidirectional flow
US5879635A (en) * 1997-03-31 1999-03-09 Nason; Frederic L. Reagent dispenser and related test kit for biological specimens
US5939252A (en) 1997-05-09 1999-08-17 Lennon; Donald J. Detachable-element assay device
US20060093524A1 (en) * 1997-06-20 2006-05-04 Dakocytomation Denmark A/S Device for taking and examining samples
US7264780B1 (en) * 1997-06-20 2007-09-04 Oxoid (Ely) Limited Device for taking and examining samples
US6524530B1 (en) * 1997-10-13 2003-02-25 Kikkoman Corporation Sample collecting member and wiping inspection instrument
EP1024354A4 (en) * 1997-10-13 2004-08-04 Kikkoman Corp Sample collecting member and wiping inspection instrument
EP1024354A1 (en) * 1997-10-13 2000-08-02 Kikkoman Corporation Sample collecting member and wiping inspection instrument
USD408082S (en) * 1997-12-29 1999-04-13 Charm Sciences, Inc. Pocket-size sanitation test kit
US6274314B1 (en) 1998-04-02 2001-08-14 Nyxis Neurotherapies, Inc. Diagnostic assay for the modified nucleosides pseudouridine, 7-methyladenosine, or 1-methyladenosine
US5869003A (en) * 1998-04-15 1999-02-09 Nason; Frederic L. Self contained diagnostic test unit
US6248294B1 (en) 1998-04-15 2001-06-19 Frederic L. Nason Self contained diagnostic test unit
US7001719B2 (en) 1999-10-01 2006-02-21 3M Innovative Properties Company Devices and methods for microorganism detection
US6737266B1 (en) * 1999-10-01 2004-05-18 3M Innovative Properties Company Devices and methods for microorganism detection
US20040191892A1 (en) * 1999-10-01 2004-09-30 3M Innovative Properties Company Devices and methods for microorganism detection
WO2001036099A1 (en) * 1999-11-15 2001-05-25 Dipro Diagnostics Handels Gmbh Disposable test device
US7517699B2 (en) 2000-04-14 2009-04-14 Quantrx Biomedical Corporation Positive detection lateral-flow apparatus and method for small and large analytes
US6699722B2 (en) 2000-04-14 2004-03-02 A-Fem Medical Corporation Positive detection lateral-flow apparatus and method for small and large analytes
US6372516B1 (en) 2000-09-07 2002-04-16 Sun Biomedical Laboratories, Inc. Lateral flow test device
US6458322B1 (en) 2000-09-08 2002-10-01 Bioavailability Systems, Llc Method for simplified shipping of clinical specimens and optional direct analysis
US20020136663A1 (en) * 2000-09-08 2002-09-26 Bioavailability Systems, Llc Method for simplified shipping of clinical specimens and optional direct analysis
US20040170536A1 (en) * 2001-03-05 2004-09-02 Victory Daykin Biological specimen collection apparatus
US20020176806A1 (en) * 2001-03-26 2002-11-28 Weiping Ren Application of a disposable tube in biomedical and immunological assays
US6565808B2 (en) 2001-05-18 2003-05-20 Acon Laboratories Line test device and methods of use
US6890484B2 (en) 2001-05-18 2005-05-10 Acon Laboratories, Inc. In line test device and methods of use
US20050227372A1 (en) * 2001-07-12 2005-10-13 Khan Waheed N Diagnostic test kit
US20030013121A1 (en) * 2001-07-12 2003-01-16 Khan Waheed N. Diagnostic test kit
US20050238535A1 (en) * 2001-10-03 2005-10-27 20/20 Genesystems, Inc. Rapid assay, method and system for detecting biowarfare agents
US20030143752A1 (en) * 2001-12-06 2003-07-31 Biocontrol Systems, Inc. Sample collection and testing system
US7544961B2 (en) 2001-12-06 2009-06-09 Biocontrol Systems, Inc. Sample collection and testing system including a rotatable shaft with a helical guiding member to translate longitudinal motion of a slidable shaft into rotational motion
US7030403B2 (en) 2001-12-06 2006-04-18 Biocontrol Systems, Inc. Sample collection and bioluminescent sample testing system
US20080272283A1 (en) * 2001-12-06 2008-11-06 Feldsine Philip T Sample collection and testing system
US7399984B2 (en) 2001-12-06 2008-07-15 Biocontrol Systems Inc. Sample collection and testing system having a displacement member causing reagent to come into contact with a sample collection surface
US7691326B2 (en) * 2002-01-04 2010-04-06 Sorenson Genomics, L.L.C. System for non-invasive extraction, secure handling and storage and facile processing and facile processing of a specimen
US20030129738A1 (en) * 2002-01-04 2003-07-10 Sorenson James Levoy System, apparatus, composition and method for non-invasive extraction, secure handling and storage and facile processing and facile processing of a specimen
US6703216B2 (en) 2002-03-14 2004-03-09 The Regents Of The University Of California Methods, compositions and apparatuses for detection of gamma-hydroxybutyric acid (GHB)
US6924498B2 (en) 2002-04-24 2005-08-02 Biocontrol Systems, Inc. Sample collection and testing system
US20040220748A1 (en) * 2002-04-24 2004-11-04 Biocontrol Systems, Inc. Sample collection and testing system
US20030235518A1 (en) * 2002-06-21 2003-12-25 Shea Laurence R. Array assay devices and methods of using the same
US9568479B2 (en) 2002-08-13 2017-02-14 N-Dia, Inc. Devices and methods for detecting amniotic fluid in vaginal secretions
US7709272B2 (en) 2002-08-13 2010-05-04 N-Dia, Inc. Devices and methods for detecting amniotic fluid in vaginal secretions
US10422802B2 (en) 2002-08-13 2019-09-24 Qiagen Sciences, Llc Devices and methods for detecting amniotic fluid in vaginal secretions
US20060240498A1 (en) * 2002-08-13 2006-10-26 Michael Friedman Devices and methods for detecting amniotic fluid in vaginal secretions
US8114610B2 (en) 2002-08-13 2012-02-14 N-Dia, Inc. Devices and methods for detecting amniotic fluid in vaginal secretions
EP2204654A1 (en) 2002-08-13 2010-07-07 N-Dia, Inc. Devices and methods for detecting amniotic fluid in vaginal secretions
US9494596B2 (en) 2002-08-13 2016-11-15 N-Dia, Inc. Devices and methods for detecting amniotic fluid in vaginal secretions
US9429580B2 (en) 2002-08-13 2016-08-30 N-Dia, Inc. Devices and methods for detecting amniotic fluid in vaginal secretions
US20040214316A1 (en) * 2003-04-24 2004-10-28 O'connell David Personal cell sampling kit
US7232681B2 (en) * 2003-04-24 2007-06-19 O'connell David Personal cell sampling kit
US7132249B1 (en) 2003-05-12 2006-11-07 Charm Sciences, Inc. Method of determining allergenic food on surfaces
US7494781B1 (en) 2003-05-12 2009-02-24 Charm Sciences, Inc. Sensitive method for detecting low levels of ATP
US20050084842A1 (en) * 2003-10-20 2005-04-21 O'connor Amanda L. Diagnostic test device and method of using same
US6991898B2 (en) 2003-10-20 2006-01-31 Kimberly-Clark Worldwide, Inc. Diagnostic test device and method of using same
US20080260581A1 (en) * 2004-01-21 2008-10-23 Orion Diagnostica Oy Sampling and Assay Device
US9327284B2 (en) * 2004-01-21 2016-05-03 Orion Diagnostica Oy Sampling and assay device
US20050255533A1 (en) * 2004-02-10 2005-11-17 Brendan Bioscience, Llc Comprehensive food allergy test
US7824878B2 (en) 2004-05-11 2010-11-02 Charm Sciences, Inc. Sensitive method for detecting low levels of ATP
US7919325B2 (en) 2004-05-24 2011-04-05 Authentix, Inc. Method and apparatus for monitoring liquid for the presence of an additive
US7569397B2 (en) 2004-12-16 2009-08-04 Chembio Diagnostic Systems, Inc. Immunoassay devices and use thereof
US20080254444A1 (en) * 2004-12-16 2008-10-16 Javanbakhsh Esfandiari Immunoassay Devices and Use Thereof
US7993871B2 (en) 2004-12-22 2011-08-09 Charm Sciences, Inc. Sampling method and device
US20080206740A1 (en) * 2004-12-22 2008-08-28 Skiffington Richard T Sampling Method and Device
US7780915B2 (en) 2005-02-16 2010-08-24 Epitope Diagnostcs, Inc. Fecal sample test device and methods of use
US20060188939A1 (en) * 2005-02-16 2006-08-24 Ping Gao Fecal sample test device and methods of use
US8877450B2 (en) 2005-03-11 2014-11-04 Chembio Diagnostic Systems, Inc. Dual path immunoassay device
EP3425399A1 (en) 2005-03-11 2019-01-09 Chembio Diagnostic Systems, Inc. Dual path immunoassay device
US9784734B2 (en) 2005-03-11 2017-10-10 Chembio Diagnostic Systems, Inc. Dual path immunoassay device
US8507259B2 (en) 2005-03-11 2013-08-13 Chembio Diagnostics Systems, Inc. Dual path immunoassay device
US20080302193A1 (en) * 2005-08-02 2008-12-11 Bommarito G Marco Apparatus and Method For Detecting an Analyte
US20080302192A1 (en) * 2005-08-02 2008-12-11 Gonzalez Bernard A Apparatus and Method For Detecting an Analyte
US20080299600A1 (en) * 2005-08-02 2008-12-04 Bommarito G Marco Apparatus Assembly and Method for Detecting an Analyte
US20090019953A1 (en) * 2005-08-02 2009-01-22 3 Innovative Properties Company Apparatus And Method For Detecting An Analyte
US8012427B2 (en) 2005-08-02 2011-09-06 3M Innovative Properties Company Apparatus and method for detecting an analyte
US20100047927A1 (en) * 2005-12-16 2010-02-25 Bayer Cropscience K.K. Kit for measurement of termite insecticide active ingredient by immunoassay method
US8323904B2 (en) 2005-12-16 2012-12-04 Bayer Cropscience Ag Kit for measurement of termite insecticide active ingredient by immunoassay method
US20090053694A1 (en) * 2005-12-26 2009-02-26 Kriksunov Leo B Photochemically Amplified Bioassay
US8476064B2 (en) 2006-05-09 2013-07-02 Charm Sciences, Inc. Inhibition assay method and device for detection of antibiotics
US20100285572A1 (en) * 2006-05-09 2010-11-11 Salter Robert S Inhibition Assay Method and Device for Detection of Antibiotics
US20100136670A1 (en) * 2007-05-04 2010-06-03 Markovsky Robert J Sampling Method and Device
WO2008154813A1 (en) 2007-06-15 2008-12-24 Xiamen University Monoclonal antibodies binding to avian influenza virus subtype h5 haemagglutinin and uses thereof
EP2716656A1 (en) 2007-06-15 2014-04-09 Xiamen University Monoclonal antibodies binding to avian influenza virus subtype H5 haemagglutinin and uses thereof
US10688458B2 (en) 2007-06-21 2020-06-23 Gen-Probe Incorporated System and method of using multi-chambered receptacles
US8052929B2 (en) 2007-06-21 2011-11-08 Gen-Probe Incorporated Gravity-assisted mixing methods
US8491178B2 (en) 2007-06-21 2013-07-23 Gen-Probe Incorporated Instruments and methods for mixing the contents of a detection chamber
US9744506B2 (en) 2007-06-21 2017-08-29 Gen-Probe Incorporated Instruments for mixing the contents of a detection chamber
US8828654B2 (en) 2007-06-21 2014-09-09 Gen-Probe Incorporated Methods for manipulating liquid substances in multi-chambered receptacles
US10744469B2 (en) 2007-06-21 2020-08-18 Gen-Probe Incorporated Multi-chambered receptacles
US11235294B2 (en) 2007-06-21 2022-02-01 Gen-Probe Incorporated System and method of using multi-chambered receptacles
US8480976B2 (en) 2007-06-21 2013-07-09 Gen-Probe Incorporated Instruments and methods for mixing the contents of a detection chamber
US11235295B2 (en) 2007-06-21 2022-02-01 Gen-Probe Incorporated System and method of using multi-chambered receptacles
US7780336B2 (en) 2007-06-21 2010-08-24 Gen-Probe Incorporated Instruments and methods for mixing the contents of a detection chamber
US8048375B2 (en) 2007-06-21 2011-11-01 Gen-Probe Incorporated Gravity-assisted mixing methods
US8735055B2 (en) 2007-06-21 2014-05-27 Gen-Probe Incorporated Methods of concentrating an analyte
US7767447B2 (en) 2007-06-21 2010-08-03 Gen-Probe Incorporated Instruments and methods for exposing a receptacle to multiple thermal zones
US8765367B2 (en) 2007-06-21 2014-07-01 Gen-Probe Incorporated Methods and instruments for processing a sample in a multi-chambered receptacle
US8784745B2 (en) 2007-06-21 2014-07-22 Gen-Probe Incorporated Methods for manipulating liquid substances in multi-chambered receptacles
US20090030341A1 (en) * 2007-07-27 2009-01-29 3M Innovative Properties Company Sample release system
US20090030342A1 (en) * 2007-07-27 2009-01-29 3M Innovative Properties Company Apparatus and method for releasing a sample of material
US20110179887A1 (en) * 2008-02-15 2011-07-28 Cobian Paul J Sample acquisition device
US8677843B2 (en) 2008-02-15 2014-03-25 3M Innovative Properties Company Sample acquisition device
US20110146419A1 (en) * 2008-02-15 2011-06-23 Gonzalez Bernard A Sample acquisition device
US8476008B2 (en) 2008-07-23 2013-07-02 Diabetomics, Llc Methods for detecting pre-diabetes and diabetes
US20110124022A1 (en) * 2008-07-23 2011-05-26 Diabetomics, Llc Methods for detecting pre-diabetes and diabetes
US8962341B2 (en) 2008-12-12 2015-02-24 The Commonwealth Medical College Cell-based detection of APF through its interaction with CKAP4 for diagnosis of interstitial cystitis
US9075045B2 (en) 2008-12-12 2015-07-07 The Commonwealth Medical College Cell-based detection of APF through its interaction with CKAP4 for diagnosis of interstitial cystitis
US8530175B2 (en) 2009-05-11 2013-09-10 Diabetomics, Llc Methods for detecting pre-diabetes and diabetes using differential protein glycosylation
US8497076B2 (en) 2009-05-11 2013-07-30 Diabetomics, Llc Methods for detecting pre-diabetes and diabetes using differential protein glycosylation
US8497077B2 (en) 2009-05-11 2013-07-30 Diabetomics, Llc Methods for detecting pre-diabetes and diabetes using differential protein glycosylation
US8168396B2 (en) 2009-05-11 2012-05-01 Diabetomics, Llc Methods for detecting pre-diabetes and diabetes using differential protein glycosylation
US9739773B1 (en) 2010-08-13 2017-08-22 David Gordon Bermudes Compositions and methods for determining successful immunization by one or more vaccines
US8603835B2 (en) 2011-02-10 2013-12-10 Chembio Diagnostic Systems, Inc. Reduced step dual path immunoassay device and method
EP3418397A1 (en) 2012-01-24 2018-12-26 CD Diagnostics, Inc. System for detecting infection in synovial fluid
US8585982B1 (en) * 2012-01-31 2013-11-19 The United States Of America As Represented By The Secretary Of The Navy Field colorimetric test device
US11634758B2 (en) 2012-02-03 2023-04-25 Axxin Pty Ltd Nucleic acid amplification and detection apparatus and method
EP3415919A1 (en) 2012-02-07 2018-12-19 Intuitive Biosciences Inc. Mycobacterium tuberculosis specific peptides for detection of infection or immunization in non-human primates
US10119968B2 (en) 2012-06-02 2018-11-06 Test Anywhere Technology Self-contained diagnostic test with advanceable test strip
US10684232B2 (en) 2012-06-29 2020-06-16 Biocontrol Systems, Inc. Sample collection and bioluminescent analysis system
US9446406B2 (en) 2012-06-29 2016-09-20 Biocontrol Systems, Inc. Sample collection and bioluminescent analysis system
WO2014087255A2 (en) 2012-11-21 2014-06-12 Oslo Universitetssykehus Hf Systems and methods for monitoring biological fluids
EP3637105A2 (en) 2013-01-02 2020-04-15 Qiagen Sciences, LLC Methods for predicting time-to-delivery in pregnant women
US11353464B2 (en) 2013-01-02 2022-06-07 Qiagen Sciences, Llc Methods for predicting time-to-delivery in pregnant women
US9891233B2 (en) 2013-01-02 2018-02-13 N-Dia, Inc. Methods for predicting time-to-delivery in pregnant women
US20200009550A1 (en) * 2013-05-24 2020-01-09 Premier Biotech, Inc. Multi-stage oral-fluid testing device
US20160121322A1 (en) * 2013-05-24 2016-05-05 Premier Biotech, Inc. Multi-stage oral-fluid testing device
US10035146B2 (en) * 2013-05-24 2018-07-31 Premier Biotech, Inc. Multi-stage oral-fluid testing device
US20220023858A1 (en) * 2013-05-24 2022-01-27 Premier Biotech, Inc. Multi-stage oral-fluid testing device
US11090648B2 (en) * 2013-05-24 2021-08-17 Premier Biotech, Inc. Multi-stage oral-fluid testing device
US20150024384A1 (en) * 2013-07-22 2015-01-22 Kianoosh Peyvan Sequential delivery device and method
US9308508B2 (en) * 2013-07-22 2016-04-12 Kianoosh Peyvan Sequential delivery device and method
US20150191690A1 (en) * 2014-01-06 2015-07-09 Lawrence Livermore National Security, Llc Compositions and methods for pathogen transport
US9243222B2 (en) * 2014-01-06 2016-01-26 Lawrence Livermore National Security, Llc Compositions and methods for pathogen transport
US10908158B2 (en) 2014-04-02 2021-02-02 Chembio Diagnostic Systems, Inc. Immunoassay methods utilizing trapping conjugate
US10473655B2 (en) 2014-04-02 2019-11-12 Chembio Diagnostic Systems, Inc. Immunoassay utilizing trapping conjugate
US9885710B2 (en) 2014-04-02 2018-02-06 Chembio Diagnostic Systems, Inc. Immunoassay utilizing trapping conjugate
US10976315B2 (en) 2014-04-02 2021-04-13 Chembio Diagnostic Systems, Inc. Immunoassay utilizing trapping conjugate
US10598657B2 (en) 2014-04-02 2020-03-24 Chembio Diagnostic Systems, Inc. Immunoassay utilizing trapping conjugate
US9891216B2 (en) 2014-04-02 2018-02-13 Chembio Diagnostic Systems, Inc. Immunoassay methods utilizing trapping conjugate
US10690667B2 (en) 2014-10-27 2020-06-23 Chembio Diagnostic Systems, Inc. Rapid screening assay for qualitative detection of multiple febrile illnesses
US9927443B2 (en) 2015-04-10 2018-03-27 Conquerab Inc. Risk assessment for therapeutic drugs
WO2016172660A1 (en) 2015-04-23 2016-10-27 Board Of Regents Of The Nevada System Of Higher Education, On Behalf Of The University Of Nevada, Reno Fungal detection using mannan epitope
WO2017023929A1 (en) 2015-08-04 2017-02-09 Cd Diagnostics, Inc. Methods for detecting adverse local tissue reaction (altr) necrosis
WO2017077392A1 (en) 2015-11-06 2017-05-11 Oslo Universitetssykehus Hf Methods and devices for detecting methanol poisoning using formate oxidase
WO2017100454A1 (en) 2015-12-09 2017-06-15 Intuitive Biosciences, Inc. Automated silver enhancement system
EP3978619A1 (en) 2015-12-09 2022-04-06 Intuitive Biosciences, Inc. Automated silver enhancement system
WO2017147186A1 (en) 2016-02-22 2017-08-31 Ursure, Inc. System and method for detecting therapeutic agents to monitor adherence to a treatment regimen
US9903866B2 (en) 2016-04-05 2018-02-27 Conquerab Inc. Portable devices for detection of antibodies against therapeutic drugs
WO2017180909A1 (en) * 2016-04-13 2017-10-19 Nextgen Jane, Inc. Sample collection and preservation devices, systems and methods
WO2017178554A1 (en) 2016-04-13 2017-10-19 INSERM (Institut National de la Santé et de la Recherche Médicale) Methods and kits for the rapid detection of the escherichia coli o25b-st131 clone
US11446011B2 (en) 2016-04-13 2022-09-20 Nextgen Jane, Inc. Sample collection and preservation devices, systems and methods
US11864740B2 (en) 2016-04-13 2024-01-09 Nextgen Jane, Inc. Sample collection and preservation devices, systems and methods
US10935555B2 (en) 2016-12-22 2021-03-02 Qiagen Sciences, Llc Determining candidate for induction of labor
US10656164B2 (en) 2016-12-22 2020-05-19 Qiagen Sciences, Llc Screening asymptomatic pregnant woman for preterm birth
US10837914B2 (en) 2016-12-28 2020-11-17 Neogen Corporation Implement analyzing device and method for utilizing the same
US9833783B1 (en) 2016-12-28 2017-12-05 Neogen Corporation Fluid retainer cartridge assembly and method for utilizing the same
US11768158B2 (en) 2016-12-28 2023-09-26 Neogen Corporation Implement analyzing device and method for utilizing the same
WO2018203145A1 (en) 2017-05-03 2018-11-08 Oslo Universitetssykehus Hf Systems and methods for monitoring biological fluids
US11709175B2 (en) * 2017-09-27 2023-07-25 Axxin Pty Ltd Diagnostic test system and method utilizing a closure/sample dispensing mechanism to dispense a sample subvolume for testing
US20200278368A1 (en) * 2017-09-27 2020-09-03 Axxin Pty Ltd Diagnostic test system and method
WO2020014353A1 (en) 2018-07-11 2020-01-16 The United States Of America, As Represented By The Secretary, Department Of Health And Human Services Monoclonal antibody for the detection of the antiretroviral drug emtricitabine (ftc, 2',3'-dideoxy-5-fluoro-3'-thiacytidine)
US11293839B2 (en) 2018-08-16 2022-04-05 Epitope Biotechnology Co., Ltd. Device for fecal sample collection and extraction
US11300576B2 (en) 2019-01-29 2022-04-12 Arizona Board Of Regents On Behalf Of Arizona State University DARPin reagents that distinguish Alzheimer's disease and Parkinson's disease samples
USD956962S1 (en) * 2019-07-30 2022-07-05 Illinois Tool Works Inc. Swab
USD993400S1 (en) 2019-07-30 2023-07-25 Illinois Tool Works Inc. Swab
USD946751S1 (en) * 2019-08-12 2022-03-22 Siemens Healthcare Diagnostics Inc. Dual-ended swab
WO2022223555A1 (en) 2021-04-23 2022-10-27 SOLIOS DIAGNOSTICS GmbH Test device, test method, and manufacturing method for the test device for performing a test aimed at detecting an organic structure
DE102021110457A1 (en) 2021-04-23 2022-10-27 SOLIOS DIAGNOSTICS GmbH Method, test device and test kit for performing an assay directed to the detection of an organic structure
US20240050955A1 (en) * 2023-03-03 2024-02-15 Ustar Biotechnologies (Hangzhou) Ltd. Multi-functional integrated molecular test cartridge and application thereof

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EP0293447A4 (en) 1990-12-19
WO1988004431A1 (en) 1988-06-16
ATE110852T1 (en) 1994-09-15
DE3750473T2 (en) 1995-04-20
JPH01502054A (en) 1989-07-13
DE3750473D1 (en) 1994-10-06
EP0293447A1 (en) 1988-12-07
AU1051888A (en) 1988-06-30

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